AccessGUDID - DEVICE: TSX™ Transseptal Needle (00884450451717)

GUDID

Device Identifier (DI) Information

Brand Name: TSX™ Transseptal Needle
Version or Model: 00884450451717
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004TSXNEEDLE100
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450451717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47248	Cardiac transseptal needle, single-use	A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRC	Trocar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7e0debb-3721-4845-a4f4-d370c462ef96
Public Version Date: April 19, 2021
Public Version Number: 3
DI Record Publish Date: October 14, 2020